Lupin Ltd

eNavvi, an online pharmacy founded by physicians, is joining forces with Mark Cuban Cost Plus Drug Company (MCCPDC) to allow physicians to prescribe medications directly via eNavvi's digital prescription pad to more than 7,000 independent pharmacies and national grocery pharmacy chains. The aim is to streamline the prescribing process, improve convenience and enhance prescription-price transparency. In 2023, the two companies collaborated to deliver prescription-cost transparency to enable eNavvi's Marketplace to provide real-time cash-price transparency directly to physicians. Now, according to the two companies, because of integration, physicians will be able to use eNavvi's platform to compare medication prices in real time and prescribe directly from eNavvi. Additionally, patients will have the option to pick up their discounted medication prescriptions from local pharmacies. Healthcare providers can sign up via eNavvi's website, where they will be able to access the enhanced prescribing platform. Following an identity-verification process, healthcare providers can prescribe directly to a broad network of retail and online pharmacies, including major grocery chains. "Our expansion into the retail pharmacy sector exemplifies our commitment to simplifying the prescribing process for physicians and patients," Simon Chang, CEO of eNavvi, said in a statement. "By expanding with Cost Plus Drugs and integrating with major grocery pharmacies, we minimize steps and enhance convenience, ultimately benefiting both providers and patients." THE LARGER TREND Earlier this week, Mark Cuban, founder of Mark Cuban Cost Plus Drug Company, told MobiHealthNews that it is vital for government officials to think about and understand the hierarchy regarding the prescription drug market and to evaluate and set laws around drug pricing. Cuban asserted that PBMs' role needed to change in order to lower prescription drug costs. Earlier this month, Avanlee Care announced that it was integrating MCCPDC's offerings into its Ava app to give affordable medications to caregivers and their families. Avanlee said it intends to improve existing eldercare technology by combining necessary tools and services in one location for unpaid family caregivers. Through the alliance, Avanlee Care's users will have access to MCCPDC's online pharmacy via the Ava app. In 2023, MCCPDC partnered with pharmaceutical company Lupin Limited and the COPD Foundation to expand access to Tiotropium Bromide Inhalation Powder for chronic obstructive pulmonary disease patients in the U.S. That same year, MCCPDC partnered with Posterity Health, a male fertility and sexual healthcare company, to provide men access to medications to treat infertility, sexual dysfunction and low testosterone. In June, eNavvi announced the launch of its revamped user interface and introduced its Rx Marketplace with integrated ePrescribe functionality. The update was designed to enhance the user experience, while making it easier for healthcare providers to prescribe medications, and for patients to access affordable cash-priced prescriptions.

Company Grants Teva a License to Market Generic Galafold® Beginning in January 2037PRINCETON, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that it has entered into a License Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Amicus in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD® (migalastat) 123mg capsules prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD® in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD® patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1 as the remaining active party and the litigation stay remains in place for Lupin2. As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on X and LinkedIn. Forward Looking StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements concerning: the terms of the settlement agreement with Teva, expectations regarding the impact of the settlement agreement and submission of the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties, including the unfavorable outcome of other litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to GALAFOLD, which may lead to competition from generic drug manufacturers; the outcome of any review of the settlement agreement by the United States Federal Trade Commission and United States Department of Justice; the U.S. FDA may approve Teva's ANDA significantly in advance of the entry date; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K for the year ended December 31, 2023, and on Form 10-Q for the quarter ended June 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof. CONTACT: Investors:Amicus TherapeuticsAndrew FaughnanVice President, Investor Relationsafaughnan@amicusrx.com (609) 662-3809 Media:Amicus TherapeuticsDiana MooreHead of Global Corporate Affairs and Communicationsdmoore@amicusrx.com (609) 662-5079 FOLD–G 1 Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.2 Lupin LTD and Lupin Pharmaceuticals, Inc.

The agreement will allow Lupin to expand its gastroenterology portfolio in the Indian market. Credit: Orawan Pattarawimonchai/Shutterstock. Pharmaceutical company Lupin has announced a non-exclusive patent licence agreement with Takeda Pharmaceutical for the commercialisation of Vonoprazan tablets in India. The medication will be sold under the brand name Lupin’s Lupivon in the Indian market. Vonoprazan will be made available in 10mg and 20mg strengths. A potassium-competitive acid blocker (P-CAB), the drug differs from traditional acid suppressants such as proton pump inhibitors by offering rapid and complete proton pump inhibition from the first dose. Its longer duration of action also ensures effective control of nocturnal acid breakthrough, and it can be dosed independently of meals. See Also: Trilaciclib by G1 Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval SX-682 by Syntrix Pharmaceuticals for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval The Drug Controller General of India (DCGI) has approved Vonoprazan for the treatment of gastric ulcers, reflux esophagitis and duodenal ulcers, and as part of the Helicobacter pylori eradication regimen. The agreement will allow Lupin to expand its gastroenterology portfolio in the Indian market, where acid peptic disorders (APD) are claimed to be highly prevalent. APDs encompassing gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD), impact a significant portion of the Indian population. GERD prevalence varies from 5% to 28.5%, while PUD affects approximately 8%. Older age, higher body mass index, non-vegetarian diets, consumption of tea or coffee and lifestyle choices such as smoking and alcohol intake are the risk factors for GERD. Lupin India Region Formulations president Rajeev Sibal stated: “We are very pleased to commercialise Vonoprazan, a novel treatment option for acid peptic disorders. “This is a further step in strengthening our gastroenterology portfolio and is in line with our commitment to introduce innovative medicines to address the unmet needs of our patients.” In November 2023, Lupin introduced the fixed-dose triple combination (FDC) drug , Vilfuro-G, to manage chronic obstructive pulmonary disease in India.